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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
__________________
Date of
Report (Date of earliest event reported):
November
10, 2008
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-31812
|
58-2301143
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
|
111
Barclay Boulevard
Lincolnshire,
Illinois
|
60069
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(847)
478-0500
(Registrant’s
Telephone Number, Including Area Code)
N/A
(Former
Name or Former Address, If Changed Since Last Report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
|
£
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
£
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
£
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
£
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
Section
2 – Financial Information
Item 2.02. Results of Operations and
Financial Condition.
On
November 10, 2008, BioSante Pharmaceuticals, Inc. publicly announced its
financial results for the third quarter ended September 30, 2008. For
further information, please refer to the press release attached hereto as
Exhibit 99.1, which is incorporated by reference herein.
The
information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability
of that section, and shall not be incorporated by reference into any filings
made by BioSante Pharmaceuticals, Inc. under the Securities Act of 1933, as
amended, or the Exchange Act, except as may be expressly set forth by specific
reference in such filing.
Section
9 – Financial Statements and Exhibits
Item
9.01. Financial Statements and Exhibits.
(c) Exhibits.
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release issued November 10,
2008
|
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
BIOSANTE
PHARMACEUTICALS, INC.
By: /s/ Phillip B.
Donenberg
Phillip
B. Donenberg
Chief
Financial Officer, Treasurer and Secretary
Dated: November 10,
2008
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued November 10, 2008
|
Furnished
herewith
|
BioSante
Pharmaceuticals, Inc.
111
Barclay Boulevard
Lincolnshire,
Illinois 60069
www.biosantepharma.com
FOR
IMMEDIATE
RELEASE
NASDAQ:
BPAX
BioSante
Pharmaceuticals Reports Third Quarter 2008 Financial Results
LibiGel®
Continues To Be Focus in Treatment of Female Sexual Dysfunction
LINCOLNSHIRE, Illinois - (November
10, 2008) --- BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today
reported its financial results for the third quarter and nine months ended
September 30, 2008, and stated that LibiGel (testosterone gel) for the treatment
of female sexual dysfunction continues as BioSante’s number one
focus. LibiGel currently is in three Phase III clinical trials
to support submission and approval of a new drug application (NDA) with the
FDA. The LibiGel Phase III safety and efficacy trials are being
conducted under an FDA approved SPA.
BioSante
incurred a net loss of approximately $6.6 million or ($0.24) per share for the
quarter ended September 30, 2008 and $16.3 million or ($0.60) per share for the
nine months ended September 30, 2008, compared to a net loss of $1.7 million or
($0.06) per share and $5.9 million or ($0.24) per share for the same respective
periods in 2007. The increased net loss was due primarily to
anticipated increased expenses to conduct the three ongoing LibiGel Phase III
clinical trials.
The
Company’s cash, cash equivalents and short-term investments as of September 30,
2008 were approximately $17.5 million, as compared to approximately $22.8
million as of June 30, 2008.
About
BioSante Pharmaceuticals, Inc.
BioSante
is a specialty pharmaceutical company focused on developing products for female
sexual health, menopause, contraception and male hypogonadism. BioSante's lead
products include LibiGel®
(transdermal testosterone gel) in Phase III clinical development by BioSante
under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol
Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™
(estradiol gel) developed through FDA approval by BioSante, indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with menopause,
currently marketed in the U.S. Also in development are Bio-T-Gel™, a
testosterone gel for male hypogonadism, and an oral contraceptive in Phase II
clinical development using BioSante patented technology. The
current market in the U.S. for estrogen and testosterone products is
approximately $2.5 billion and for oral contraceptives approximately $3.0
billion. The company also is developing its calcium phosphate technology (CaP)
for novel vaccines, drug delivery and aesthetic medicine
(BioLook™). Additional information is available online at: www.biosantepharma.com.
For more
information, please contact:
McKinney/Chicago
Alan
Zachary
(312)
944-6784 ext. 316;
azachary@mckinneychicago.com;
Investor
Relations:
The
Investor Relations Group
Investors: Adam
S. Holdsworth / Christine Berni 212-825-3210
or
Media: Laura
Colontrelle /Janet Vasquez 212-825-3210